NCT05816382 · Takeda
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
What this study is about
The main aim is to evaluate the safety and how well patients handle the treatment of TAK-861 on participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
View original scientific description
The main aim is to evaluate the safety and tolerability of TAK-861 on participants with type 1 narcolepsy, who were exposed to previously tested doses of TAK-861.
Interventions
DRUG
TAK-861
TAK-861 tablets
Primary outcome measures
Number of Participants With at Least One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: From signing the informed consent form up to follow-up of 4 weeks after the last dose (Up to approximately 5 years)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving trial intervention.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 1\. Participant with a diagnosis of NT1 who has completed a controlled study with TAK-861, and for whom the investigator has no clinical objection to their enrollment.
Exclusion criteria
- Participant has a treatment-emergent adverse event (TEAE) that remains severe at the time of rollover related to the study drug from the parent study or discontinued because of TEAEs in the parent study. 2. Participant has a risk of suicide according to endorsement of item 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS). 3. The participant has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values \>1.5 times the upper limit of normal (ULN). 4. Participant has a current medical disorder, other than narcolepsy with or without cataplexy, associated with excessive daytime sleepiness (EDS). 5. Participant has current active major depressive episode (MDE) or has had an active MDE in the past 6 months. 6. Participant has developed (within the last 6
Where
- Birmingham, Alabama
- Redwood City, California
- Santa Ana, California
- Colorado Springs, Colorado
- Orlando, Florida
- Atlanta, Georgia
- Gainesville, Georgia
- Newton, Massachusetts
- Novi, Michigan
- Denver, North Carolina
- Huntersville, North Carolina
- Cincinnati, Ohio
And 6 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 5, 2026 · Source of record for eligibility and locations